The Food and Drug Administration (FDA) is ordering the biotechnology firm 23andMe to immediately stop selling its heralded DNA test kits.
23andMe never proved that its tests are effective and never received clearance to market them from the FDA, the agency said in a letter sent on Friday. That’s a violation of the Federal Food, Drug and Cosmetic Act.
The company’s kit tests saliva samples, sells for $99 and claims to help diagnose risks of health conditions and possible negative reactions to certain medications.
“The more you know about your DNA, the more you know about yourself,” 23andMe says in its online marketing materials.
But according to the FDA, the firm never affirmed that it works as a diagnosis device.
The federal agency said that tests are “particularly concerning” because false negatives or false positives could lead patients to undergo surgery or intensive screening.
“The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported,” the head of the FDA's diagnostic medical devices office, Alberto Gutierrez, wrote in the letter.
According to the FDA, the test kits are medical devices and need to get approval before they can be sold to the public. The agency said it has explained the need for 23andMe to get approval “on numerous occasions,” including during more than 14 face-to-face meetings.
23andMe has not even started some tests to support a decision to allow marketing, it said, and the FDA has “not received any communication” since May.
“We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission,” 23andMe said in a statement to The Hill. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
The test kit was named the “Invention of the Year” by TIME magazine in 2008.
The FDA is ordering the company to take “corrective actions” within 15 days. If it does not, the agency may issue fines or seize its devices.